To help the drug and device development industries account for human factors (HF) in their combination product trials, the FDA is releasing draft guidance on employing use-related risk analysis (URRA),…
Multiple and repeated violations found in Sun Pharmaceuticals’ Dadra, India facility during a December 2023 FDA inspection have resulted in a Warning Letter following the company’s inadequate responses to a…
CBER has published an updated list of guidance topics for development during 2024. Source: Drug Industry Daily
As the second session of the 118th Congress begins, FDAnews will track important pending legislation, that has been acted on since Dec. 31, 2023 to keep you updated on laws…
The new definition of Alzheimer’s as any abnormal level of amyloid beta or tau — even in the absence of symptoms — could vastly expand the market for treating the…
The FDA is proposing to adopt a new guideline from the International Council for Harmonisation (ICH) on the use of real-world data (RWD) in pharmacoepidemiological studies of drug, vaccine and…
Senator Bill Cassidy (R-LA), ranking member of the Senate Health, Education, Labor and Pensions (HELP) Committee, called out the FDA in a letter pressing federal agencies on how they will…
An Indian plant that makes a number of drugs and active pharmaceutical ingredients (API) was socked with a six-observation Form 483 noting multiple problems with validation testing for API and…
This week, the FDA published a final guidance for small businesses on LDTs. The long-awaited draft guidance on diversity in clinical trials was also published. The agency modified its list…
It looks like glucagon-like peptide 1 receptor agonists (GLP-1) are pulling another trick out of their seemingly bottomless black bag. In addition to regulating blood sugar, trimming fat and cutting…